Trial reportFrontiers in endocrinology2021
Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study.
Trial report in Frontiers in endocrinology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01838551 (An Open Label Study to Assess the Safety and Efficacy of COR-003), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- The effect of hypercortisolism treatment on dyslipidemia in Cushing syndrome: systematic review and meta-analysis.The Journal of clinical endocrinology and metabolism · 2026Pooled it
- Improvement in clinical features of hypercortisolism during osilodrostat treatment: findings from the Phase III LINC 3 trial in Cushing's disease.Journal of endocrinological investigation · 2024Trial
- Levoketoconazole treatment in endogenous Cushing's syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes.European journal of endocrinology · 2022Trial
- Trial
- Update and Practical Recommendations for the Use of Medical Treatment of Cushing Syndrome.Endocrine reviews · 2026Review
- New Trends in Treating Cushing's Disease.TouchREVIEWS in endocrinology · 2024Article
- An Overview of Cardiovascular Risk in Pituitary Disorders.Medicina (Kaunas, Lithuania) · 2024Review
- Medical treatment of functional pituitary adenomas, trials and tribulations.Journal of neuro-oncology · 2024Review
- Current and Emerging Pharmacological Therapies for Cushing's Disease.Current pharmaceutical design · 2024Review
- Safe long-term therapy of Cushing's syndrome over 37 years with mitotane.Frontiers in endocrinology · 2024Review
- Epidemiology and Management of Hypertension and Diabetes Mellitus in Patients with Mild Autonomous Cortisol Secretion: A Review.Biomedicines · 2023Review
- Medical treatment of Cushing's disease with concurrent diabetes mellitus.Frontiers in endocrinology · 2023Review
- Levoketoconazole.Hospital pharmacy · 2022Article
- Long-term outcomes of osilodrostat in Cushing's disease: LINC 3 study extension.European journal of endocrinology · 2022Article
- Management and Medical Therapy of Mild Hypercortisolism.International journal of molecular sciences · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 11 institutions in 6 countries.
Funding
Abstract
Background: Cushing's syndrome (CS) is associated with numerous comorbidities, including diabetes mellitus (DM). Levoketoconazole, an orally administered ketoconazole stereoisomer, is in clinical trials for the treatment of CS. Methods: SONICS, a prospective, open-label, phase 3 study in adults with confirmed CS and mean 24-h urinary free cortisol (mUFC) ≥1.5× ULN, included dose-titration, 6-month maintenance, and 6-month extension phases. This subanalysis evaluated the efficacy of levoketoconazole in patients with DM (n = 28) or without DM (n = 49) who entered the maintenance phase. Safety was evaluated in the overall population (N = 94) during the dose-titration and maintenance phases. Results: Normalization of mUFC at the end of maintenance phase (EoM), without a dose increase during maintenance (SONICS primary endpoint) was observed in 46% of patients with DM (95% CI, 28 to 66%; Conclusions: Treatment with levoketoconazole led to sustained normalization of mUFC and improvement in glycemic control that was more pronounced in patients with DM. Clinical Trial Registration: (ClinicalTrials.gov), NCT01838551.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.